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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01495-1
Product Name/Description	SynchroMed II Implantable Drug Infusion Pump Model Numbers: 8637-20, 8637-40 ARTG Number: 97770
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/12/2017
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic is recalling the prior configuration of SynchroMed II implantable drug infusion pumps, as a new configuration is available with an enhanced motor design. This recall action only relates to unimplanted devices. Medtronic has received regulatory approval for a design change to the SynchroMed II implantable drug infusion pump. This design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. All SynchroMed II pumps are now being manufactured and distributed with this change.
Recall Action	Recall for Product Correction
Recall Action Instructions	Medtronic will liaise with hospitals to review their inventory to locate affected pumps. Medtronic will arrange return and replacement of affected pumps. This action has been closed out on the 22/10/2018.
Contact Information	1800 652 972 - Medtronic Neuromodulation Patient Services